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The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. (K202243, Class 2, Regulation 878.4430, Product Code: QAI.); Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. (Class I, 510(k) Exempt, Regulation 878.4022, Product code: NAE.); SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.; Sani-Cloth AF3: Sanitizing cloth available for purchase along with device to sanitize between uses.

The provided FDA 510(k) clearance letter (K220506) for the SkinPen® Precision System does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for its clinical indications (improving the appearance of wrinkles of the neck and facial acne scars).

The letter states, "No Clinical testing was conducted as part of this submission." This submission is a "Special 510(k)" for a modification to an already cleared device (K202243 SkinPen Precision System). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" would have been part of the original 510(k) for the predicate device, K202243, or a prior submission that established the clinical effectiveness for the indications for use.

Instead, this submission focuses on a non-clinical performance testing related to a change in the disinfecting cloth used with the device.

Here's a breakdown of the information that is present, in relation to your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• No clinical acceptance criteria or performance data are provided in this document for the indications of use (wrinkles of the neck, facial acne scars).
• Non-clinical (cleaning validation) acceptance criteria and performance:
  • Acceptance Criteria for Cleaning Validation: The goal was to confirm that the Sani-Cloth AF3 is sufficient for bacterial removal from the device even under worst-case contamination scenarios. The implicit acceptance criterion is that the bacteria are effectively removed.
  • Reported Device Performance (Cleaning Validation): "it was confirmed that the bacteria were removed from the device when cleaned with Sani-Cloth AF3... The new Sani-Cloth AF3 shows the same or improved results than the previously used Sani-Cloth HB."

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Test Set: Not applicable, as no clinical testing was performed for this submission.
• Non-clinical (Cleaning Validation) Test Set: The document describes "application of bacteria on the SkinPen device surface." The exact sample size (number of devices, number of wipes, etc.) is not explicitly stated, but it refers to "worst-case conditions."
• Data Provenance: Not explicitly stated, but likely conducted in a laboratory setting as part of the manufacturer's testing for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Clinical Test Set: Not applicable.
• Non-clinical (Cleaning Validation) Test Set: The "ground truth" here is the presence or absence of bacteria (before and after cleaning). This would be established by standard microbiological laboratory techniques, not by human experts in the context of clinical interpretation. The qualifications of the microbiologists or lab technicians are not provided.

4. Adjudication Method for the Test Set

• Clinical Test Set: Not applicable.
• Non-clinical (Cleaning Validation) Test Set: Not applicable in the sense of clinical adjudication. The result (bacteria removed or not) would be determined by laboratory assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance

• This device is a microneedling system, not an AI diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• This device is a microneedling system, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Clinical Ground Truth: For the clinical indications (wrinkles and acne scars), the ground truth for the original predicate device clearance would likely have been based on clinician assessments (e.g., blinded expert photographic evaluations, severity scales) and/or patient-reported outcomes. This document does not provide that information.
• Non-clinical (Cleaning Validation) Ground Truth: The ground truth for the cleaning validation was the microbiological assessment of bacterial presence/absence on the device surface.

8. The Sample Size for the Training Set

• Clinical Training Set: Not applicable, as no clinical studies were performed for this submission, and it's not an AI/model development submission.
• Non-clinical (Cleaning Validation) Training Set: Not applicable. This was a validation study, not a model training process.

9. How the Ground Truth for the Training Set Was Established

• Not applicable for the reasons stated above.

In summary, this document primarily outlines the regulatory clearance (510(k)) for a minor modification (change in disinfecting wipe) to an already cleared microneedling device. It does not provide the details of clinical acceptance criteria or studies proving clinical effectiveness, as those would have been part of the original clearance for the predicate device (K202243). The only "study" mentioned is a non-clinical cleaning validation.

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The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.

Here's a breakdown of the acceptance criteria and study details for the SkinPen Precision System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes "effectiveness endpoints" and presents study results that demonstrate the device's ability to improve the appearance of wrinkles on the neck. The implicit acceptance criterion is a statistically significant and clinically meaningful improvement in wrinkle appearance and positive patient satisfaction, as evidenced by the measured outcomes.

• 11.5% of subjects received a '2: much improved' grading.
• 31.5% of subjects received a '3: improved' grading.
• 57% received a '4: no change' grading. (Total of 43% showed improvement) |
  | Secondary Effectiveness: Subject's Global Aesthetic Improvement Scale (SGAIS) | Clinically meaningful proportion of subjects reporting "Improved," "Much Improved," or "Very Much Improved" ratings. | At 3 months post-treatment: 22 out of 32 subjects (68.8%) reported some percentage of improvement in the appearance of their wrinkles.
  (This suggests a high level of patient-perceived improvement). |
  | Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 1 (Improvement noticed) | High percentage of subjects reporting "Yes" to noticing improvement in fine lines and wrinkles. | 1-Month Post-Treatment: 93.8% (30 out of 32) reported "Yes".
  3-Months Post-Treatment: 71.9% (23 out of 32) reported "Yes". (High initial and sustained patient perception of improvement). |
  | Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 2 (Satisfaction) | High percentage of subjects reporting "Favorable" satisfaction. | 1-Month Post-Treatment: 87.5% (28 out of 32) reported "Favorable".
  3-Months Post-Treatment: 75.0% (24 out of 32) reported "Favorable". (High level of patient satisfaction). |
  | Secondary Effectiveness: Patient Satisfaction Questionnaire - Question 3 (Recommendation) | High percentage of subjects reporting "Yes" to recommending the treatment. | 1-Month Post-Treatment: 80.6% (25 out of 31) reported "Yes".
  3-Months Post-Treatment: 65.6% (21 out of 32) reported "Yes". (Strong willingness to recommend, though decreasing slightly over time). |
  | Safety Endpoint (Adverse Events) | Absence of serious device-related adverse events. | No adverse events related to the SkinPen Precision treatment were observed on the face and neck during the study. (Common transient treatment responses like dryness, redness, burning, itching, peeling, tenderness were reported, lasting 1-7 days). |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Clinical Study (Test Set): 35 subjects initially enrolled (2 male, 33 female). The detailed demographic table (Table 1) shows N=32 for the reported results, implying 32 subjects completed the study protocol in some capacity for the neck wrinkle indication.
• Data Provenance: The study was a "single center study" (location not explicitly stated, but typically US-based for FDA submissions). It was a prospective clinical study conducted to specifically evaluate the device for the new indication (wrinkles on the neck).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Two separate independent blinded Board Certified Physicians.
• Qualifications of Experts: Board Certified Physicians. (No specific years of experience are mentioned).

4. Adjudication Method for the Test Set

• The document states that the G. Lemperle Wrinkle Scale and Clinician's Global Aesthetic Improvement Assessment were "graded by two blinded graders." It does not specify an adjudication method such as 2+1, 3+1, or any other consensus mechanism if the two graders disagreed. It only reports the results based on these two independent blinded assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This study evaluates the direct clinical effectiveness of a physical microneedling device for aesthetic improvement, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, the concept of human reader improvement with/without AI assistance is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, this is not an algorithm. The SkinPen Precision System is a physical microneedling device. The study evaluates the device's direct effect on patients, interpreted by human clinicians for efficacy and safety.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for evaluating the device's effectiveness was primarily based on:
  • Expert Assessment: Graded by two independent, blinded Board Certified Physicians using standardized aesthetic scales (G. Lemperle Wrinkle Scale, Clinician's Global Aesthetic Improvement Assessment) based on digital images. This leans towards expert consensus if their results were combined or averaged, though the method isn't detailed.
  • Patient-Reported Outcomes/Subjective Assessment: Subject Global Aesthetic Improvement Scale and Patient Satisfaction Questionnaires provided outcomes data directly from the subjects.
  • Safety Data: Monitoring of adverse events and subject safety diaries also contributed to the overall outcomes data.

8. The Sample Size for the Training Set

• This clinical study was conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of wrinkles on the neck. This appears to be a pivotal clinical trial for the new indication, meaning it serves as the primary evidence for this specific claim, not a "training set" for an algorithm. There is no mention of a separate training set for an algorithm as the device itself is not an algorithm.
• The document mentions a previous clinical study for acne scars (DEN160029) but does not provide details about its sample size in this submission.

9. How the Ground Truth for the Training Set Was Established

• As this is not an AI/algorithm-driven device with a training set, the concept of establishing ground truth for a training set does not apply. The "ground truth" for establishing the device's efficacy and safety for its intended use was derived directly from the prospective clinical study as outlined in section 7.

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SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.

The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen Precision) and a sterile needle cartridge (SkinPen Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen Precision System treatment kit is provided separately and contains the following:

• SkinPen Precision Cartridge: sterile, disposable needle cartridge. Not to be . resterilized or reused.
• . SkinPen BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen Precision
• . Lift HG: hydrogel wound dressing (without drugs and/or biologics) to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

SkinPen Precision System: Acceptance Criteria and Performance Study

The SkinPen Precision System is a microneedling device intended to improve the appearance of facial acne scars in adults aged 22 years or older. The regulatory information outlines various non-clinical and clinical studies conducted to ensure its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for clinical effectiveness in a singular table, but rather presents performance goals through the clinical study outcomes. The regulatory framework defines special controls that serve as acceptance criteria for safety and performance aspects.

Here's an interpretation combining the clinical effectiveness results and the special controls as acceptance criteria:

Note: This table synthesizes information. The original document does not explicitly present clinical "acceptance criteria" but rather states the results and concludes that the probable benefits outweigh the probable risks.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Clinical Study (Effectiveness): 20 subjects treated with the SkinPen Precision System.
  • Clinical Study (Safety - includes prototype): 41 subjects (20 SkinPen Precision, 21 prototype device).
• Data Provenance: The general location of the clinical study is not explicitly stated as a country but it was a "single center" study. The method was prospective (clinical study conducted to evaluate safety and effectiveness).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: 2 blinded evaluators.
• Qualifications of Experts: Board Certified Dermatologists. Specific experience (e.g., 10 years) is not provided.

4. Adjudication Method for the Test Set

The document states, "2 blinded evaluators would evaluate images after completion of the clinical study." It does not specify an adjudication method like 2+1 or 3+1 if their ratings differed. It implies both evaluators independently graded the images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus those without AI assistance was not done. This study focused on the device's effectiveness on subjects, with expert graders evaluating subject images, not evaluating AI performance or AI-assisted human performance.

6. Standalone (Algorithm Only) Performance Study

This device is a physical microneedling system, not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted. The performance studies were for the physical device itself.

7. Type of Ground Truth Used (for Clinical Effectiveness)

The ground truth for clinical effectiveness was established by expert consensus (two blinded dermatologists) grading digital images of facial acne scars using the "Acne Scar Assessment Scale" and the "Clinician's Global Aesthetic Improvement Assessment (CGAIS)". The Acne Scar Assessment Scale was also stated to be a "validated scale." Patient-reported outcomes (Self-assessed Scar Improvement Scale, Subject Global Aesthetic Improvement Scale, Patient Satisfaction Questionnaire) were also collected as secondary endpoints.

8. Sample Size for the Training Set

This report does not describe a machine learning algorithm that requires a "training set." The clinical study data was used to demonstrate the device's performance, not to train an AI model.

9. How the Ground Truth for the Training Set Was Established

As noted above, there was no training set in the context of an AI/ML algorithm. The clinical data was used for direct evaluation of the device.

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